Saluda Medical: First “Pacemaker for the Spine” Gains FDA Approval

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ARTICLE SUMMARY:

Saluda Medical’s Evoke System, which senses the nerves’ response to stimulation and instantaneously adjusts therapy, is the first ever closed-loop spinal cord stimulation system. Its recent FDA approval for chronic pain rests on superior efficacy seen in the most rigorous PMA study ever done in the field of neuromodulation.

In March 2022, Saluda Medical Pty Limited (Artaremon, Australia) gained FDA approval for a long-heralded and unique advancement in interventional pain: the Evoke Spinal Cord Stimulation (SCS) System , a closed loop system that, in responding to signals from an individual’s nervous system, has achieved the highest long-term rates of efficacy while addressing major challenges of other therapies, such as frequent visits for reprogramming.

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